validation of an objective instrument to measure hot flashes during menopause

Conditions: Menopause; Hot Flashes

Summary: the overarching aim of this study is to assess the validity of the ibutton®, a dual temperature and humidity sensing device (ds1923; maxim integratedtm), as an objective method to assess hot flash incidence and dynamics in both a real world (ambulatory) and controlled (laboratory) setting. this study will test the overarching hypothesis that both self-report hot flashes in both an ambulatory and laboratory setting will correlate (confirm) the temperature and humidity sensing observed via the ibutton® technology.

using ibutton® technology as an objective instrument to measure hot flash dynamics, the investigators will validate the technology in 12 perimenopausal women ages 45-60 y and bmi 18.5-40 kg/m2 who experience greater than or equal to 4 hot flashes per day. first, the investigators will validate the ibutton® technology against self-report (subjective) hot flash incidence in a real world, ambulatory condition (via a hot flash journal). next, the investigators will validate the ibutton® technology during a controlled, laboratory-stimulated hot flash using a tube-lined suit that circulates warm water uniformly around the lower limbs (med-engtm). during the stimulated hot flash, the investigators will simultaneously measure core body temperature, skin blood flow, skin temperature, sweat rate, and heart rate alongside the ibutton® to correlate (confirm) the observed thermoregulatory changes and further assess validity. to date, existing studies using ibuttons® to assess changes in skin temperature have been conducted. each subject will undergo a two-phased screening to determine eligibility. pre-enrollment measurements will include standard anthropometrics (weight, height), vital signs (blood pressure, heart rate), fasting blood draw, and questionnaires, as well as a 7-day hot flash journal that captures frequency and severity screening. post-enrollment measurements will include simultaneous objective (via ibuttons®) and subjective (via self-report journal) hot flash recordings (i.e., field testing), as well as a final laboratory visit will be conducted at louisiana state university's school of kinesiology and include body composition assessment, as well as the following assessments during a stimulated hot flash -- core temperature, skin blood flow, skin temperature, sweat rate, and heart rate.

Eligibility criteria:
inclusion criteria: * healthy female * ages 45-60 y * bmi between 18.5 kg/m2 and 40 kg/m2 (inclusive) * self-reported ≥4 hot flashes per day (for 4 out of the 7 days) (via 7-d hot flash journal) * meets both criteria for "peri-menopause (late phase)" classification: (1) experiences menopause-related symptoms (including hot flashes); (2) has hot gone 12 months in a row without a menstrual cycle; however, has sometimes more than 60 days between cycles. * medically cleared for participation by the medical investigator exclusion criteria: * current smokers, or having smoked within the last 3 months * history of diabetes (or other metabolic diseases) * history of neurological disease * history of cardiovascular disease * taking hormone replacement therapy, or other therapies/supplements designed to reduce severity of menopause symptoms (e.g., hot flashes) * pregnant, planning to become pregnant, or currently breastfeeding